Gottlieb: Is the FDA in Safe Hands?

Not one to mince his words, President Donald Trump has made repeated attacks on the US Food and Drug Administration’s (FDA) approval process. Although many within the pharma industry would welcome less regulatory red tape, most draw a line at axing the rules completely. Which is why Trump’s choice of Scott Gottlieb to head up the FDA appears to be so well received within the industry.

Who is Scott Gottlieb?

Dr. Gottlieb is a medical school professor and cancer survivor with a background working with pharma companies. Gottlieb gained experience in several senior positions at the FDA during the George W. Bush administration. He’s an industry insider, and for many that means he’s a safer pair of hands than other nominees.

However, his deep-rooted links to pharma span more than a decade – and that may work against him. Described by Public Citizen as an “unprecedented web of big pharma ties,” those links run far and wide. His work as a consultant and speaker earned him hundreds of thousands of dollars from medical-product companies, and he is a venture partner at a company that funds multiple firms working in the biopharmaceutical and medical device sectors.

Gottlieb is vocal about his views of the FDA, calling for faster approvals, more transparency, and greater decision-making power for doctors. In a 2012 article for National Affairs, Gottlieb describe the FDA’s drug approval process as “cumbersome.” This is an opinion that has been echoed by Trump, who has also described the agency as “slow and burdensome.”

Yet, according to many independent researchers, the FDA is the fastest regulatory agency in the world. Researchers say the reason endless medical breakthroughs aren’t coming to market is because discovering them takes a huge amount of time and effort.

What would Gottlieb’s FDA leadership look like?

With Gottlieb as commissioner of the FDA, we could see the faster, more flexible approach to evidence. This approach is already in effect within the agency’s cancer division. If it was to be adopted across the agency as a whole, it could mean more application approvals and doctors taking on the role of gatekeepers. But speedier approval doesn’t necessarily translate into better outcomes.

In the National Affairs article, Gottlieb wrote the “FDA is driven by a profound lack of confidence in the ability of doctors to make careful judgments. The agency regulates drug makers, but it does not regulate doctors.”

However, putting more power in the hands of doctors might not be the most strategic move. Expecting doctors to vet the data on drugs to ensure their safety and value to patients is largely unrealistic. The vetting process takes time and transferring responsibility would place a huge burden on doctors.

Gottlieb also believes by modernizing the agency’s approval process, the cost of prescription drugs could be driven down. This, in theory, could end the tendency for drug prices to stay at the same level long after their patents have expired.

The concerns around Gottlieb

Gottlieb might be the first choice for many in biopharma, but outside the industry people are yet to be convinced. Speaking about Gottlieb’s appointment, Michael Carome, director of Public Citizen’s Health Research Group said, “In addition to being entangled with multiple industry ties, he’s advocated for a dangerous deregulatory approach to the review of medications.”

US Democrats have also voiced concerns. Sherrod Brown, Senator for Ohio argues the FDA needs a leader who won’t “roll over for his big pharma friends.”

The main concern is Gottlieb’s appointment serves the interests of the industry, not those of the patients. On the flip side, his FDA experience and medical background have worked in his favor. Founder and chair of Friends of Cancer Research Ellen Sigal said he has “the skills necessary to continue to lead the FDA to be patient-centered and science-focused.”

Or, in the words of Paul Howard, a senior fellow with the conservative Manhattan Institute: “He has led investments in new medicines and in new approaches in therapeutics. It’s extraordinarily helpful for someone who is leading the agency at a time of tremendous technological change to have that kind of vision and experience.”

Gottlieb might come to the role with more financial conflicts of interest than seen in previous commissioners, but his supporters are adamant he’s the right person for the job.

Author: Ryan Clark

Ryan Clark is a strategic client director working on partnerships between CCC and commercial clients. Ryan has been with CCC over five years and has worked in rightsholder relations and business development prior to joining the strategic client group. Ryan enjoys spending time with his family, and following Bruins hockey and Ireland rugby in his time away from work.